Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar

NCT07702916 | Enrolling By Invitation

• 2 other identifiers: HS-FY2025-210AEARCTR-0014423
• Study Type: interventional
• Target: 3,080
• Locations: 1 country
• Sites: 1

Brief Summary

A previous study in schools in rural Madagascar found that a bundle of hygiene-focused interventions substantially improved girls' learning outcomes. This study disentangles the effects of physical infrastructure (latrines, handwashing basins) from other intervention components (peer sensitization and free sanitary pad distribution) in a cluster-randomized trial across 140 secondary schools in the Amoron'i Mania region. The trial originally measured learning and psychosocial wellbeing outcomes and was prospectively registered with the AEA RCT Registry (AEARCTR-0014423). The study team is now also collecting secondary health biomarker outcomes (e.g., salivary cortisol and blood-based C-reactive protein) and is registering those health biomarker endpoints with ClinicalTrials.gov.

Conditions

Urinary Tract Infections; Malnutrition; Inflammation; Stress; Menstrual Hygiene

Keywords

menstrual hygiene management; menstrual hygiene intervention; menstrual stigma reduction intervention; adolescents; school-based intervention; WASH (water, sanitation, and hygiene); Madagascar; cluster-randomized trial; biomarkers; psychosocial stress; cortisol; inflammation; anemia; urinary tract infection; environmental enteric dysfunction; gut microbiome; menstrual stigma

Outcome Measures

Primary Outcomes (6)

• Learning - Academic Test Scores

  Standardized math/literacy test scores and official school grades (140-school full evaluation sample and 80-school biomarker subsample)

  Up to 19 months

• Learning - School Grades

  Official school grades (140-school full evaluation sample and and 80-school biomarker subsample)

  Up to 19 months

• Psychosocial Wellbeing - Heart Rate

  Objective stress measure: heart rate, beats per minute (140-school full evaluation sample and 80-school biomarker subsample)

  Up to 19 months

• Psychosocial Wellbeing - Blood Pressure

  Objective stress measure: systolic/diastolic blood pressure, mmHg (140-school full evaluation sample and 80-school biomarker subsample)

  Up to 19 months

• Psychosocial Wellbeing - Salivary Cortisol Reactivity

  Salivary cortisol reactivity (80-school biomarker subsample). Cortisol reactivity, calculated as the area under the curve with respect to increase (AUCi), based on samples collected at clinic arrival (baseline), 5-8 minutes pre-venipuncture, and 20 minutes post-venipuncture. AUCi is calculated using the trapezoidal method: the area under the curve with respect to ground (AUCg) is first calculated by summing the areas of the trapezoids formed between each pair of consecutive cortisol values and their corresponding time interval, then subtracting the area under the baseline value across the total sampling duration. This is expressed as AUCg = Σ\[(Ci + Ci+1)/2 × Ti\], where Ci is the cortisol concentration at a given timepoint, Ci+1 is the concentration at the subsequent timepoint, and Ti is the time interval between them. AUCi = AUCg - (baseline cortisol × total sampling duration). Reported in µg/dL×min.

  Up to 19 months

• Menstrual stigma

  Self-reported menstrual stigma (140-school full evaluation sample)

  Up to 17 months

Secondary Outcomes (17)

• Hygiene Knowledge

  Up to 17 months

• Hygiene Behavior

  Up to 17 months

• Menstrual Knowledge

  Up to 17 months

• Menstrual Behavior

  Up to 17 months

• Student/Teacher Motivation

  Up to 17 months

Study Arms (4)

Control

NO INTERVENTION

No intervention

School infrastructure only

EXPERIMENTAL

Construction of latrines and handwashing basins

Other: School infrastructure

Peer leadership/sensitization + sanitary pads

EXPERIMENTAL

Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

Behavioral: Peer leadership/sensitization + sanitary pads

Full package

EXPERIMENTAL

Combination of all interventions: Construction of latrines and handwashing basins and Peer leadership/sensitization + sanitary pads

Behavioral: Peer leadership/sensitization + sanitary pads; Other: School infrastructure

Interventions

Peer leadership/sensitization + sanitary pads BEHAVIORAL

Young Girl Leaders program, teacher sensitization, WASH competition, free sanitary pad vouchers

Full package; Peer leadership/sensitization + sanitary pads

School infrastructure OTHER

Construction of latrines and handwashing basins

Full package; School infrastructure only

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Girl identified in the Kilonga 2 evaluation sample (randomly selected during the December 2024-January 2025 baseline from class registers across the 140 participating schools); participants were 11-20 years old at baseline enrollment and are approximately 12-21 years old at the time of endline/health-outcomes data collection (May-August 2026)
• Full evaluation sample (n\~3,080; \~22 girls/school): all girls in the Kilonga 2 sample across the 140 schools are eligible for the cognitive, self-reported psychosocial, and non-biospecimen health outcomes, collected at the social-science endline.
• Biomarker subsample (n\~1,360; \~17 girls/school): girls attending one of the 80 schools selected for the health biomarker subsample (logistically accessible for biospecimen collection and cold-chain maintenance) are additionally eligible for salivary cortisol and blood-based C-reactive protein outcomes.
• Informed consent obtained from parent/legal guardian, and assent obtained from the participant herself

You may not qualify if:

• Adolescents (or their parent/legal guardian) who refuse to participate or who withdraw consent/assent at any time
• Adolescents for whom sample collection is judged impossible or contraindicated at the time of collection (e.g., health status precluding collection)

Sponsors & Collaborators

• University of California Santa Cruz: lead
• Paris School of Economics: collaborator
• Laboratoire d'Analyses Médicales Malagasy (LA2M): collaborator
• Consultant Associates: collaborator
• Care International: collaborator

Study Sites (1)

Laboratoire d'Analyses Médicales Malagasy

Antananarivo, Madagascar

Location

MeSH Terms

Conditions

Urinary Tract Infections; Malnutrition; Inflammation; Anemia

Interventions

Menstrual Hygiene Products

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Audrie Lin, PhD, MPH

  University of California Santa Cruz

  PRINCIPAL INVESTIGATOR

• Karen Macours, PhD

  Paris School of Economics

  PRINCIPAL INVESTIGATOR

• Duncan Webb, PhD

  Nova School of Business and Economics

  PRINCIPAL INVESTIGATOR

• Mariachiara Iannuzzi, MS

  Paris School of Economics

  PRINCIPAL INVESTIGATOR

• Oscar M Díaz, MS

  Paris School of Economics

  PRINCIPAL INVESTIGATOR

• William Amedanou, MS

  Paris School of Economics

  PRINCIPAL INVESTIGATOR

• Juliet Ellenbach, BS

  University of California Santa Cruz

  PRINCIPAL INVESTIGATOR

• Eliane Z Ralison

  Consultant Associates

  PRINCIPAL INVESTIGATOR

• Andry M Andrianarivelo, MD

  Laboratoire d'Analyses Médicales Malagasy

  PRINCIPAL INVESTIGATOR

• Ianja I Razanadrakoto, MD

  Laboratoire d'Analyses Médicales Malagasy

  PRINCIPAL INVESTIGATOR

• Tantely J Ramontalambo, MD

  Laboratoire d'Analyses Médicales Malagasy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The outcome assessment team is separate from the implementation team, however due to the nature of the interventions there may be intervention contents visible during the assessment. Data analysis will be masked to randomization status of clusters.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2×2 factorial design crossing two intervention components, each present or absent: (1) physical infrastructure (construction of latrines and handwashing basins) and (2) a sensitization and sanitary pad distribution bundle (Young Girl Leaders peer program, teacher sensitization, WASH committee/competition, and free sanitary pad vouchers). The four resulting arms are: Control (neither component), Infrastructure only, Sensitization+pads only, and the Full package (both components combined). The factorial structure allows estimation of each component's independent effect as well as any complementarity (interaction) between the two - for example, whether girls can only act on improved hygiene knowledge if handwashing infrastructure is also available at school.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 14, 2026
• Study Start: October 1, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)